510(k) K011000 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
TRAM 2001 MODULE
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 29, 2001 |
| Received | Apr 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2014 | GE Healthcare, LLC GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonata Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.